NCT05557396

Brief Summary

This methodological research is aimed to examine the effectiveness of the methods used to estimate the internal length of the nasogastric tube and to determine the most reliable method for correct placement of the nasogastric tube in adults. The study will be carried out between 01 September 2022 and 01 September 2023 with 155 patients who hospitalized in the anesthesia and reamination intensive care and general intensive care units of Aydın Adnan Menderes University Application and Research Hospital. The internal tube length measurement methodologies will utilized to confirm proper NGT placement. A total of 5 groups will be included in the study, including 1 control (NEX measurement method) and 4 experimental groups, (Experiment 1: CoNEX measurement method, Experiment 2: XEN+10 cm measurement method, Experiment 3: GWNUF measurement method, Experiment 4: EXU-NE Method measurement method).The "gold standard" reference method will used for comparison was radiography. Research data will be analyzed in SPSS (Statistical Package for Social Sciences) for Windows 25.0 statistical package program. Descriptive statistical methods (number, percentage, mean, standard deviation) will be used in the evaluation of the data. The comparison between the methods used in the measurement of the nasogastric tube (NEX, CoNEX, XEN+10 cm, GWNUF, EXU-NE) and the results of the radiological evaluation (reference method) will be made with Chi-square analysis. Statistical significance will be accepted as p\<0.05.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

September 23, 2022

Last Update Submit

June 20, 2024

Conditions

Keywords

nasogastric tubeinternal tube lengthcritical carenursing

Outcome Measures

Primary Outcomes (5)

  • The CoNEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    By creating a straight line with a tape measure, first the distance between the patient's nose tip and the earlobe and then the distance between the earlobe and the xiphoid will be measured, then the nasogastric tube length to be applied to the patient will be determined according to the (NEX x 0.38696) + 36.37 cm formula. The length determined according to the result will be marked on the nasogastric tube, and the nasogastric tube will be advanced by the researcher from the patient's nose to the marked place.Immediately after the completion of the insertion process, an abdominal X-ray will be taken and the tube location will be confirmed.

    One year

  • The XEN+10 cm method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    By creating a straight line with a tape measure, the distance between the patient's xiphoid and earlobe, then the distance between the earlobe and the tip of the nose will be measured and 10 cm will be added to the measurement obtained. The location of the tube will be confirmed by taking an abdominal x-ray immediately after the placement process is completed, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

    one year

  • The GWNUF method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    Body weight will be measured without clothing on the patient, The distance between the tip of the nose and the umbilicus will be measured while the patient is in the supine position, 29.38 + (4.53 x gender) + (0.34 x distance between the tip of the nose and the umbilicus) - (0.06 x patient weight), (gender) The length of the nasogastric tube to be applied to the patient will be determined according to the formula = 1 for male patient, 0 for female patient, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the investigator from the patient's nose to the marked area, Immediately after the completion of the insertion procedure, the abdominal X-ray will be determined. The tube location will be confirmed by filming, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

    one year

  • EXU-NE method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    By creating a straight line with a tape measure, the distance between the patient's xiphoid and earlobe will be measured first (Measurement 1), The distance between the patient's xiphoid and the midline of the umbilicus will be measured (Measure 2), The two obtained measurement values will be added (Measurement 1 + Measurement 2), The distance between the patient's nose tip and earlobe will be measured (Measurement 3), Measurement 3 value will be subtracted from the sum of Measurement 1 and Measurement 2 values, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the marked place, Insertion Immediately after the completion of the procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

    One year

  • The NEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    By creating a straight line with a tape measure, first the distance between the patient's nose tip and the earlobe and then the distance between the earlobe and the xiphoid will be measured, A marking will be made on the nasogastric tube according to the length obtained from the measurement, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the nasogastric tube placement procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

    One year

Study Arms (5)

NEX (Control group)

ACTIVE COMPARATOR

Nose-ear-xiphoid measurement method (NEX), (n=31) The distance between the patient's nose tip and earlobe will be measured first, then the distance between the earlobe and the xiphoid (NEX method) Marking will be made on the nasogastric tube according to the length obtained from the measurement, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the nasogastric tube placement procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

Other: Internal Tube Length Measurement Procedures for Nazogastric Tube

CoNEX

EXPERIMENTAL

Corrected nose-earlobe-xiphoid measurement method (CoNEX), (n=31) The distance between the patient's nose tip and earlobe will be measured first, and then the distance between the earlobe and the xiphoid, The nasogastric tube length to be applied to the patient will be determined according to the formula (NEX x 0.38696) + 36.37 cm, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the nasogastric tube placement procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

Other: Internal Tube Length Measurement Procedures for Nazogastric Tube

XEN+10

EXPERIMENTAL

Xiphoid-earlobe-nose+10 cm (XEN+10), (n=31) The distance between the patient's xiphoid and earlobe will be measured first, and then the distance between the earlobe and the tip of the nose will be measured and 10 cm will be added to the obtained measurement, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the nasogastric tube placement procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

Other: Internal Tube Length Measurement Procedures for Nazogastric Tube

GWNUF

EXPERIMENTAL

Gender-weight-nose-umblikus-head flat (GWNUF), (n=31) The patient's body weight will be measured without clothes on, When the patient is in the supine position, the distance between the tip of the nose and the umbilicus will be measured, The length of the nasogastric tube to be applied to the patient according to the formula 29.38 + (4.53 x gender) + (0.34 x distance between the tip of the nose and the umbilicus) - (0.06 x patient weight), (gender = 1 for male patient, 0 for female patient) to be determined, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the insertion procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

Other: Internal Tube Length Measurement Procedures for Nazogastric Tube

EXU-NE

EXPERIMENTAL

The distance between the patient's xiphoid and earlobe will be measured first (Measurement 1), (n=31) The distance between the patient's xiphoid and the midline of the umbilicus will be measured (Measurement 2), The two obtained measurement values will be added (Measurement 1 + Measurement 2), The distance between the patient's nose tip and earlobe will be measured (Measurement 3), Measurement 3 value will be subtracted from the sum of Measurement 1 and Measurement 2 values, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the insertion procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.

Other: Internal Tube Length Measurement Procedures for Nazogastric Tube

Interventions

Different Internal Tube Length Measurement Procedures will used for the correct placement of nasogastric tube.

CoNEXEXU-NEGWNUFNEX (Control group)XEN+10

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 age,
  • Being a patient in the adult intensive care units of the hospital where the research was conducted,
  • Glasgow coma scale ≤8,

You may not qualify if:

  • Patients fed through orogastric, orojejunal, gastrostomy, jegenostomy, and ostomy,
  • Patients who are pregnant or suspected of pregnancy,
  • Patients presenting with a history of trauma,
  • Patients with esophageal varices, nasal septal deviation, upper respiratory tract and/or digestive system anomalies,
  • Patients who had a nasogastric tube inserted or whose nasogastric tube would be changed before participating in the study,
  • Patients whose nose-earlobe-xiphoid distance cannot be measured,
  • Patients who are not accepted to participate in the study by their legal guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University

Aydin, Turkey (Türkiye)

Location

Related Publications (11)

  • Chen YC, Wang LY, Chang YJ, Yang CP, Wu TJ, Lin FR, Liu SY, Wei TS. Potential risk of malposition of nasogastric tube using nose-ear-xiphoid measurement. PLoS One. 2014 Feb 10;9(2):e88046. doi: 10.1371/journal.pone.0088046. eCollection 2014.

  • Best C. How to insert a nasogastric tube and check gastric position at the bedside. Nurs Stand. 2016 May 18;30(38):36-40. doi: 10.7748/ns.30.38.36.s43.

  • Santos SC, Woith W, Freitas MI, Zeferino EB. Methods to determine the internal length of nasogastric feeding tubes: An integrative review. Int J Nurs Stud. 2016 Sep;61:95-103. doi: 10.1016/j.ijnurstu.2016.06.004. Epub 2016 Jun 15.

  • Ellett ML, Cohen MD, Perkins SM, Croffie JM, Lane KA, Austin JK. Comparing methods of determining insertion length for placing gastric tubes in children 1 month to 17 years of age. J Spec Pediatr Nurs. 2012 Jan;17(1):19-32. doi: 10.1111/j.1744-6155.2011.00302.x. Epub 2011 Sep 30.

  • Ellett ML, Beckstrand J, Flueckiger J, Perkins SM, Johnson CS. Predicting the insertion distance for placing gastric tubes. Clin Nurs Res. 2005 Feb;14(1):11-27; discussion 28-31. doi: 10.1177/1054773804270919.

  • Fan PEM, Tan SB, Farah GI, Cheok PG, Chock WT, Sutha W, Xu D, Chua W, Kwan XL, Li CL, Teo WQ, Ang SY. Adequacy of different measurement methods in determining nasogastric tube insertion lengths: An observational study. Int J Nurs Stud. 2019 Apr;92:73-78. doi: 10.1016/j.ijnurstu.2019.01.003. Epub 2019 Jan 14.

  • Malta MA, Carvalho-Junior AF, Andreollo NA, Freitas MI. [Anthropometric measures for the introduction of the nasogastric tube for enteral nutrition employing the esophagogastroduodenoscopy]. Arq Bras Cir Dig. 2013 Jun;26(2):107-11. doi: 10.1590/s0102-67202013000200007. Portuguese.

  • Taylor SJ, Allan K, McWilliam H, Toher D. Nasogastric tube depth: the 'NEX' guideline is incorrect. Br J Nurs. 2014 Jun 26-Jul 9;23(12):641-4. doi: 10.12968/bjon.2014.23.12.641.

  • Taylor SJ. Methods of Estimating Nasogastric Tube Length: All, Including "NEX," Are Unsafe. Nutr Clin Pract. 2020 Oct;35(5):864-870. doi: 10.1002/ncp.10497. Epub 2020 May 14.

  • Torsy T, Saman R, Boeykens K, Duysburgh I, Eriksson M, Verhaeghe S, Beeckman D. Accuracy of the corrected nose-earlobe-xiphoid distance formula for determining nasogastric feeding tube insertion length in intensive care unit patients: A prospective observational study. Int J Nurs Stud. 2020 Oct;110:103614. doi: 10.1016/j.ijnurstu.2020.103614. Epub 2020 May 11.

  • Torsy T, Saman R, Boeykens K, Duysburgh I, Van Damme N, Beeckman D. Comparison of Two Methods for Estimating the Tip Position of a Nasogastric Feeding Tube: A Randomized Controlled Trial. Nutr Clin Pract. 2018 Dec;33(6):843-850. doi: 10.1002/ncp.10112. Epub 2018 Jun 30.

Study Officials

  • Nihal Taskiran, PhD

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

September 1, 2022

Primary Completion

April 1, 2024

Study Completion

December 1, 2025

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Nihal Taskiran-study protocol Pakize Özçiftçi Yılmaz-informed consest form Dilek Sarı-Statistical analysis plan Tuna Şahin\_study protocol Necla Olcum- informed consent form

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
one year
Access Criteria
Reaching the target sample size

Locations